UMIN-CTR Clinical Trial

Basic information
Public title	The Usefulness of Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures in Advanced Chronic Pancreatitis
Acronym	Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures
Scientific Title	The Usefulness of Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures in Advanced Chronic Pancreatitis
Scientific Title:Acronym	Non-flared Short Fully Covered Metallic Stent for Refractory Benign Pancreatic Strictures
Region	Asia(except Japan)

Condition
Condition	To evaluate the usefulness of non-flared short fully covered self-expandable metallic stent (FCSEMS) that was designed to minimize ductal injury and migration for refractory pancreatic stricture in advanced chronic pancreatitis
Classification by specialty	Gastroenterology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the usefulness of non-flared short fully covered self-expandable metallic stent (FCSEMS) that was designed to minimize ductal injury and migration for refractory pancreatic stricture in advanced chronic pancreatitis
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Resolution of stricture : complete runoff of contrast material was observed and an inflated extraction balloon could be passed through the pancreatic duct without resistance.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Treatment
Type of intervention	Device,equipment
Interventions/Control_1	Endoscopic stenting for pancreatic duct stricture using BONASTENT M-Intraductal stent
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit	18 years-old <
Age-upper limit	90 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Symptomatic benign pancreatic duct strictures 2) Initially treated with pancreatic sphincterotomy and 1-2 plastic stent (PS) insertion 3) Recurrent painful stricture after initial stricture resolution or persistent stricture despite PS(s)
Key exclusion criteria	1) Evidence of pancreatic neoplasia on CT scan and/or EUS 2) Multiple pancreatic ductal strictures 3) Proximal pancreatic ductal strictures
Target sample size	23

Research contact person
Name of lead principal investigator	1st name Jong Ho Middle name Last name Moon
Organization	SoonChunHyang University Hospital
Division name	Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code	14584
Address	Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 14584, Korea
TEL	+82-32-621-5094
Email	jhmoon@schmc.ac.kr

Public contact
Name of contact person	1st name Yun Nah Middle name Last name Lee
Organization	SoonChunHyang University Hospital
Division name	Digestive Disease Center and Research Institute, Department of Internal Medicine
Zip code	14584
Address	Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Joma
TEL	+82-32-621-5094
Homepage URL
Email	yunnah@schmc.ac.kr

Sponsor
Institute	SoonChunHyang University Research Fund
Institute
Department

Funding Source
Organization	SoonChunHyang University Research Fund
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Soonchunhyang bucheon hospital
Address	Digestive Disease Center and Research Institute, SoonChunHyang University Bucheon Hospital, 170 Jomaru-ro, Wonmi-gu, Bucheon 14584, Korea
Tel	+82326216363
Email	irb@schmc.ac.kr

Secondary IDs
Secondary IDs	NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2021 Year 12 Month 31 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2012 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2012 Year 09 Month 06 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 01 Month 26 Day
Last modified on	2019 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040645